The Use of Indocyanine Green as a Diagnostic Adjunct for Pediatric Solid Malignancies

STATUS

Recruiting
days left to enroll

50
participants needed

45
sponsor

Roshni Dasgupta

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Updated on 19 February 2024

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cancer

ct scan

metastasis

metastatic malignancy

pulmonary metastasis

Summary

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Use of indocyanine green will augment the accuracy of identification and resection of both primary solid malignancies as well as their pulmonary metastases, where applicable We will conduct a prospective feasibility study of pediatric patients with solid malignancies with or without lung metastatases who present at the time of initial diagnosis or relapse. These patients will receive a targeted dye to aid in the resection of these metastases. We plan to assess ICG as it relates to:

Diagnostic accuracy using pathologic correlation as gold standard measure
Short and long term event free and overall survival

Description

Patients diagnosed with solid malignancies or metastatic lesions who require clinically indicated resection will be identified by their Oncologist. The oncologist will inform the subject/family about the study and ask if they may be interested in participating. If the subject/family demonstrates potential interest in the study, the Pediatric Surgery Research team will discuss the risks and benefits of pre-operative ICG administration with the patients and enrollment.

Study subjects: All patients diagnosed with solid malignancies as well as those with metastatic disease distant from the primary tumor will be potentially eligible for the study. Diagnosis will be made:

In a multimodal fashion including physical exam, radiologic evaluation (ultrasound, MRI, CT scan, etc), and sometimes biopsy.
Prior to definitive surgical resection of the newly diagnosed malignancy

Details

Condition	Metastasis, Brain Metastases, Liver Metastases, neoplasm metastasis, Brain Metastases, Liver Metastases, neoplasm metastasis, Primary Tumor, Solid Malignancies
Age	45years or below
Clinical Study Identifier	NCT04492735
Sponsor	Roshni Dasgupta
Last Modified on	19 February 2024

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Eligibility		Yes	No	Not Sure
Inclusion Criteria
	All patients with newly diagnosed solid, primary malignancies or their related
	metastatic lesions
	Diagnosis of primary or metastatic malignancy will be made by combination of
	Clinical evaluation and physical exam
	Radiologic study including ultrasound, CT scan, and/or MRI
	Pathologic diagnosis after biopsy
Exclusion Criteria
	Those patients and parents/guardians unwilling to provide consent/assent
	Pregnant and/or women who are breast feeding
	Patients with Iodine allergies

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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The Use of Indocyanine Green as a Diagnostic Adjunct for Pediatric Solid Malignancies